Method for the percutaneous suturing of a vascular puncture site

ABSTRACT

A suture applying device comprises a shaft which carries a pair of needles near its distal end. The needles are joined by a length of suture, and the shaft is used to both introduce the needles into a lumen of a body structure and to push the needles back through tissue on either side of the puncture site. After the needles have passed through the tissue, they are captured on the shaft and drawn outward through the tract, leaving a loop of suture behind to close the puncture site near the body lumen. The suture can then be tied and the knot pushed back through the tract to complete the closure. Alternatively, a locking fastener formed of a resorbable material can be placed into the penetration over the sutures and the sutures tied over the fastener.

RELATED APPLICATIONS

The present invention is a continuation of application Ser. No.07/989,611, filed Dec. 10, 1992, now issued as U.S. Pat. No. 5,417,699,which is relied on for priority by continuation-in part application Ser.No. 08/252,124, filed Jun. 1, 1994, now issued as U.S. Pat. No.5,613,974, continuation-in-part and divisional application Ser. No.08/259,410, filed Jun. 14, 1994, now issued as U.S. Pat. No. 5,779,719,continuation-in-part application Ser. No. 08/824,031, filed Mar. 26,1997 and continuation-in-part application Ser. No. 08/883,246, filedJun. 26, 1997 pending. The present application claims disclosure andnames all of the inventors presented in U.S. Pat. No. 5,417,699 and mayconstitute a continuation application. These prior applications areincorporated fully herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to devices and methods for thepercutaneous closure of body lumens. More particularly, the presentinvention relates to devices and methods for the percutaneous closure ofarterial and venous puncture sites, which are usually accessible onlythrough a tissue tract.

A number of diagnostic and interventional vascular procedures are nowperformed transluminally, where a catheter is introduced to the vascularsystem at a convenient access location and guided through the vascularsystem to a target location using established techniques. Suchprocedures require vascular access which is usually established usingthe well known Seldinger technique, as described, for example, inWilliam Grossman's "Cardiac Catheterization and Angiography," 3rd Ed.,Lea and Febiger, Philadelphia, 1986, incorporated herein by reference.

When vascular access is no longer required, the introducer sheath mustbe removed and bleeding at the puncture site stopped. One commonapproach to attempt providing hemostasis (the cessation of bleeding) isto apply external force near and upstream from the puncture site,typically by manual or "digital" compression. This approach suffers froma number of disadvantages. It is time-consuming, frequently requiringone-half hour or more of compression before hemostasis is assured. Thisprocedure is uncomfortable for the patient and frequently requiresadministering analgesics to be tolerable. Moreover, the application ofexcessive pressure can at times totally occlude the underlying bloodvessel, resulting in ischemia and/or thrombosis. Following manualcompression the patient is required to remain recumbent for at least sixand at times as long as eighteen hours under close observation to assurecontinued hemostasis. During this time renewed bleeding may occurresulting in bleeding through the tract, hematoma and/or pseudoaneurismformation as well as arteriovenous fistula formation. Thesecomplications may require blood transfusion and/or surgicalintervention. The incidence of these complications increases when thesheath size is increased and when the patient is anticoagulated. It isclear that the standard technique for arterial closure can be risky, andis expensive and onerous to the patient. While the risk of suchconditions can be reduced by using highly trained individuals, such useis both expensive and inefficient.

To overcome the problems associated with manual compression, the use ofbioabsorbable fasteners to stop bleeding has been proposed by severalgroups. Generally, these approaches rely on the placement of athrombogenic and bioabsorbable material, such as collagen, at thesuperficial arterial wall over the puncture site. While potentiallyeffective, this approach suffers from a number of problems. It can bedifficult to properly locate the interface of the overlying tissue andthe adventitial surface of the blood vessel, and locating the fastenertoo far from that surface can result in failure to provide hemostasisand subsequent hematoma and/or pseudo aneurism formation. Conversely, ifthe fastener intrudes into the arterial lumen, intravascular clotsand/or collagen pieces with thrombus attached can form and embolizedownstream causing vascular occlusion. Also, thrombus formation on thesurface of a fastener protruding into the lumen can cause a stenosiswhich can obstruct normal blood flow. Other possible complicationsinclude infection as well as adverse reactions to the collagen implant.

For these reasons, it would be desirable to provide improved devices andmethods to seal body lumen puncture sites. It would be particularlydesirable to provide percutaneous devices and methods for suturing thepuncture sites required for percutaneous vascular procedures.

2. Description of the Background Art

Devices capable of delivering pairs of needles to various tissuelocations are described in the following patents and patentapplications: U.S. Pat. Nos. 4,493,323 and 659,422; European patentapplication 140 557; and U.S.S.R patent applications 1174-036-A and1093-329- A. Other suturing and ligating devices are described in U.S.Pat. Nos. 3,665,926; 2,959,172; and 2,646,045. Devices for sealingpercutaneous vascular penetrations using various fastener structures aredescribed in U.S. Pat. Nos. 5,061,274; 5,021,059; 4,929,246; 4,890,612;4,852,568; 4,744,364; 4,587,969; and 3,939,820. Collagen fastenersealing devices are under commercial development by Datascope Corp.,Montvale, N.J., and Kensey Nash Corporation, Exton, Pa.

SUMMARY OF THE INVENTION

The present invention provides devices and methods for suturingpercutaneous lumenal puncture sites. The devices will comprise a shaft,a pair of needles removably carried near the distal end of the shaft,and a length of suture secured to and extending between the needles. Asdescribed below, the shaft is used to introduce the needles inwardlythrough the tract and puncture site and into the lumen. Thereafter, theshaft is used to draw the needles outwardly back through the tissue oneither side of the puncture site to begin forming a loop of the sutureat the intimal surface of the puncture site. The device may fartherinclude means on the shaft for capturing the pointed ends of the needlesafter they have passed through the tissue and back into the tract, andthe shaft can then be withdrawn to carry the needles and attached sutureoutwardly back through the tract. Alternatively, the shaft and needlescan be made sufficiently long so that the pointed ends of the needlesmay be drawn completely through the tract so that they-may be manuallygrasped (without the need for capture on the shaft). In either case, thefree ends of the suture can then be tied (or otherwise secured) and theresulting knot pushed back through the tract to complete the suture loopat the adventitial surface of the puncture site. The ability to providea secured suture loop at the puncture site is particularly advantageoussince a reliable closure is formed. Furthermore, suture closure ofpuncture sites has been universally accepted as the standard of care formany decades.

The devices and methods of the present invention are useful whenever itis desirable to place a tied suture loop to close a lumen puncture site,and will be particularly useful for suturing percutaneous vascularpuncture sites. The devices can achieve closure wholly through the tractpuncture site and can be manipulated entirely in a percutaneous manner.The present invention will find its greatest use in the sealing offemoral artery cannulation sites made in connection with percutaneoustransluminal procedures, such as angiography, angioplasty, atherectomy,laser ablation, stent placement, intravascular imaging, and the like.The present invention will also find use in other medical procedureswhich rely on percutaneous access to hollow body organs and lumens, suchas laparoscopic procedures, endoscopic procedures, artheroscopicprocedures, and the like.

In a particular embodiment, the device of the present inventioncomprises the shaft, pair of needles, and length of suture, generally asdescribed above. The device further comprises a sleeve received over theshaft and having a receiving area disposed near the distal end of theshaft. The device may also include means for expanding the receivingarea and drawing the needles into the expanded receiving area, in orderto capture the needles so that they may be withdrawn by the shaftthrough the tract. Conveniently, the expanding means may be anexpandable cage and the receiving area may be defined by a fabric ormesh which will engage and entrap the needles (which are preferablybarbed at their distal ends) so that they may be withdrawn by the shaft.

In a second particular aspect, the device of the present inventioncomprises a shaft, pair of needles, and length of suture, generally asdescribed above, further in combination with a guide body having aproximal end, a distal end, and means for slidably receiving theflexible shaft therethrough, typically being a central lumen. The guidebody further includes means at its distal end for retaining the pointedtips of the needles as the device is inserted through a percutaneoustract and puncture site and for guiding the needles in a desired patternso that they will penetrate the arterial wall opposite each other aroundthe puncture site. Preferably, the needles and portion of the shaftwhich extend beyond the distal end of the guide body are retained withina flexible sheath, with the suture being within or parallel to thesheath, which facilitates introduction of the device and helps align theneedles as they are withdrawn by the shaft through the tissue. In thisembodiment, the shaft and needles are sufficiently long so that theneedles may be drawn outwardly through the tissue and entirely throughthe preexisting tract while still being held on the shaft. In this way,the pointed tips of the needles will be available so that the user canmanually grasp and remove them. Securing of the suture will beaccomplished as described above.

In a further aspect of the present invention, a fastener may beintroduced over the free ends of the suture after they have been drawnoutwardly through the percutaneous tract. The fastener is pushed intothe tract to a location just superficial to the adventitial surface ofthe puncture site, and the fastener locked in place by rotating thefastener through at least one-half turn to cross over the two sutureends. The fastener may then be secured in place by tying the remainingfree ends of the suture and pushing the resulting knot down onto thefastener.

The present invention still further provides a device for introducingthe fastener just described. The fastener introducing device comprises ashaft having a proximal end and a distal end. Means at the distal end ofthe shaft are provided for detachably securing the fastener, and meansof the proximal end of the shaft are provided for selectively detachingthe fastener after it has been placed in the desired location within thepercutaneous tract. The fastener includes at least two suture-receivingslots which permit the fastener to be introduced over the suture as itis introduced inwardly through the tract. After the fastener has beenintroduced sufficiently deep to be placed over the adventitial surfaceof the puncture site, the device may be used to turn the fastener priorto fastener detachment. The device is then removed and the free ends ofthe suture tied and the resulting knot pushed back down over thefastener to secure it in place.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a suturing device constructed inaccordance with the principles of the present invention.

FIG. 2 is a detailed view of the distal end of the suturing device ofFIG. 1.

FIG. 3 is a cross-sectional view of the device of FIGS. 1 and 2, takenalong line 3--3 of FIG. 2.

FIG. 4 is a detailed view of the distal end of the sleeve element of thedevice of FIG. 1, shown in its non-collapsed state.

FIG. 5 is a view of the distal end of the sleeve element, similar toFIG. 4, shown in its collapsed configuration to define an enlargedreceiving area.

FIG. 6 is a cross-sectional view of the proximal end of the suturingdevice of FIG. 1.

FIG. 7-12 illustrate use of the suturing device of FIG. 1 in applyingand tying a suture loop through a percutaneous tract to a blood vesselwall.

FIG. 13 illustrates a fastener applying device constructed in accordancewith the principles of the present invention.

FIG. 14 is a detailed view of the distal end of the fastener applyingdevice of FIG. 13.

FIG. 15 is a cross-sectional view of the fastener applying device ofFIGS. 13 and 14, taken along line 15--15 of FIG. 14.

FIGS. 16 and 17 illustrate placement of the fastener in connection withtying of the free ends of the suture and the method of the presentinvention.

FIGS. 18 and 19 illustrate a first alternative embodiment of thefastener of the present invention.

FIGS. 20 and 21 illustrate a second alternative embodiment of thefastener of the present invention.

FIGS. 22 and 23 illustrate a third alternative embodiment of thefastener of the present invention.

FIG. 24 is an exploded view of a second embodiment of a suturing deviceconstructed in accordance with the principles of the present invention.

FIG. 25 is an enlarged view of the proximal end of the suturing deviceof FIG. 24.

FIG. 26A is an enlarged elevational view of a portion of the proximalend of the device illustrated in FIG. 25.

FIG. 26B is a cross-sectional view taken along line 26B--26B in FIG.26A.

FIG. 27A is a perspective view of the suturing device of FIG. 24, shownin an assembled configuration.

FIG. 27B is an enlarged detail view of the distal tip of the suturingdevice illustrated in FIG. 27A.

FIG. 28 illustrates the introduction of the outer sheath which forms apart of the suturing device of FIG. 24A through a percutaneous tract.

FIG. 29 illustrates placement of the remaining portions of the suturingdevice within the sheath, as introduced in FIG. 28.

FIG. 30A illustrates initial needle penetration by drawing back theneedle-carrying shaft of the suturing device introduced as in FIG. 29.

FIG. 30B is a detail view showing the needle penetration of FIG. 30A.

FIG. 31A shows the needles after they have been captured on the shaft ofthe suturing device and have been partially withdrawn through thesheath.

FIG. 31B is a detail view of the distal end of the suturing device, asillustrated in FIG. 31A.

FIG. 32 is a perspective view from inside a blood vessel illustratingthe geometry of the needle penetration afforded by the needle guidecarried at the distal end of the shaft of the suturing device of thepresent invention.

FIG. 33 illustrates the X-pattern of the tied suture applied by thesuturing device.

FIG. 34 is a perspective view of a second alternate embodiment of asuturing device constructed in accordance with the principles of thepresent invention.

FIG. 35A is a detail view of the distal end of the guide body of thesuturing device of FIG. 34, shown with the needles retracted fullywithin the guide body.

FIG. 35B is a view similar to FIG. 35A, except that the needles havebeen partially drawn back into the guide body.

FIG. 36 is a cross-sectional view of the device of FIGS. 35A and 35B,taken along line 36--36 of FIG. 35B.

FIGS. 37-40 illustrate the method of the present invention using thesuturing device of FIG. 34.

DESCRIPTION OF SPECIFIC EMBODIMENTS

Referring to FIGS. 1-3, a suture applying device 10 which is suitablefor suturing and sealing of percutaneous vascular puncture site,particularly those made to the femoral artery in a patient's groin, willbe described. It will be appreciated, however, that the device of thepresent invention can be readily adapted for use with punctures made toother hollow body organs and lumens, although it may be necessary tomodify the dimensions and other particular aspects of the device toaccommodate the different usage environment.

The device 10 of the present invention comprises an elongate body whichincludes an outer sleeve 12 and inner shaft 14. The shaft 14 is slidablypositioned within the sleeve 12, with the sleeve and shaft beinginterconnected by a proximal actuator assembly 16 (best illustrated inFIG. 6). The inner shaft 14 will be hollow, defining a guidewire lumen(not illustrated) extending from the proximal actuator assembly 16 tothe distal tip 18 of the device 10. In this way, the device 10 can beintroduced over a conventional guidewire GW to facilitate introductionand manipulation of the device throughout the procedure, as described indetail hereinafter. The suture applying device 10 will be introducedthrough a conventional introducer sheath S, shown in phantom in FIG. 1.The ability to introduce the device 10 over the guidewire is notessential to the present invention, but will generally be preferredsince most physicians desire that intravascular devices be manipulatedover a guidewire. Introduction through the introducer sheath optionallyprovides containment of the suture as they are being introduced, asdiscussed hereinafter.

Referring in particular to FIGS. 2 and 3, suture needles 20 are carriedin the suture retainer 22 which is mounted on the distal end of shaft14. The suture retainer 22 includes a pair of slots 24 which serve asreceptacles for the proximal shank portions 26 of each needle 20. Theshank portions 26 will be shaped to mate with the slots 24 so that theneedles 20 are maintained in a desired orientation. Preferably, theneedles 20 include arcuate portions proximal to the tip which firstextend radially outward from the shaft 14 but then turn back radiallyinward toward the shaft over their proximalmost portions. As describedin greater detail hereinafter, this arcuate shape is desirable since ithelps direct the needles 20 through a path in the tissue which bringsthem back into the shaft 14, where they can be captured by a capturingassembly which is described hereinafter.

Preferably, the needles will be composed of a highly resilient surgicalmetal, such as certain nickel titanium alloys, such as Nitinol®. The useof such resilient alloys permits the needles to be compressed radiallyinward as the device 10 is introduced through the introducer sheath S.The needles 20 will spring back to their original shape, as illustratedin FIGS. 1 and 2, as soon as they pass from the distal end of the sheathS.

This ability to open or spread the needles 20 after they have beenintroduced through the introducer sheath S is important to the presentinvention since it is necessary to deploy the needles on either side ofthe percutaneous penetration. Such deployment of the needles could, ofcourse, be achieved by a variety of mechanical mechanisms which wouldpositively act on the needles to deflect them outwardly in the desiredorientation. The use of inherently resilient springs, however, greatlysimplifies the design of the device since no movable mechanicalcomponents are required to achieve the desired spreading of the needles20.

The needle shanks 26 will typically be formed of stiffer material, suchas stainless steel, to provide a strong base for retention within theneedle retainer 22. Conveniently, the shanks may be formed fromstainless steel hypodermic tubing which can be placed over and affixedto the butts of the needles 20 and flattened into a desired shape. Theslots 24 can then be oriented to receive the flattened shanks 26 andhold the needles 20 in their preferred configuration as illustrated inFIG. 2.

The needles 20 are joined by a length of suture which is secured to theshank end 26 of each needle and extends therebetween. Conveniently, thesuture 30 will be coiled between the shaft 14 and each needle shank 26,as best illustrated in FIG. 3. The suture should be stored on the deviceso that it is readily left behind in the body lumen as the device 10 iswithdrawn through a percutaneous penetration, as described in greaterdetail hereinafter. To that end, it is desirable that the needleretainer 22 be smoothly shaped so that the suture can easily passthereover as the device 10 is withdrawn.

Referring now also to FIGS. 4 and 5, the device 10 will carry astructure for capturing the needles 20 after they have been drawnthrough the tissue on either side of the percutaneous penetration. Thestructure may take a variety of forms, conveniently comprising a fabricor mesh surface 32 which defines an expandable receiving area for theneedles. The needles 20 may include barbs 40 (FIG. 2) formed at or neartheir tips, and the barbs will be entrapped by the fabric or meshsurface 32 after they penetrate therethrough.

While it would be possible to provide a fixed receiving area, i.e.non-expandable, it will usually be preferable to provide a mechanism forexpanding and orienting the receiving area to aid in capturing theneedles 20. A variety of suitable expandable support structures could beprovided, with the exemplary support structure being formed integrallyas an expandable cage in the distal end of sleeve 12. The expandablecage includes a plurality of axial ribs 42 having hinged regions 44 sothat the ribs may be expanded radially outward by compressing the sleeve12 against a stop member 46 (mounted on the shaft 14 as best seen inFIG. 2), as will be described in more detail hereinafter.

In a preferred aspect of the present invention, the hinged regions 44 onaxial ribs 42 of the cage structure on sleeve 12 will be unevenlyaxially spaced. By providing both symmetric hinge location, i.e. locatedin the middle of the rib, as well as asymmetric hinge location, theresulting asymmetric shape of the expandable cage will present a widertarget of open windows for incoming needles 20. In this way, efficientcapture of the barbed ends 40 of the needles 20 can be achieved.

Referring now in particular to FIG. 6, the proximal actuating assembly16 includes a housing base 50 which is attached to the proximal end ofsleeve 12 and a housing cap 52 which is secured to the housing base. Theshaft 14 passes through an open interior 54 of the housing cap 52 andpasses proximally outward through an aperture 56. A handle 58 isattached to the proximal end of the shaft 14 and permits a user toaxially translate the shaft 14 relative to the sleeve 12. A compressionspring 60 is mounted within the opening interior 54 of the housing cap52 and acts against a piston element 62 which is fixedly secured to theshaft 14. The piston element 62 is located so that it lies against adistal travel stop 64 formed in the housing base 50 when the shaft 14 isdisposed at the distal limit of its travel, as illustrated in FIG. 7.

The handle 58 can be used to draw the shaft 14 in the proximal axialdirection until the piston element 62 engages an annular proximal travelstop 66 formed within the housing cap 52, as illustrated in broken linein FIG. 6. With the shaft 14 thus in its most proximal position, thecage structure will have been expanded and the needles 20 drawn into thereceiving area, as illustrated in FIG. 9 and discussed in more detailhereinafter.

Referring now to FIGS. 7-12 use of the device 10 in applying and tying asuture loop in a blood vessel wall will be described in more detail.Referring in particular to FIG. 7, the device 10 is introduced throughan introducer sheath S which may have been previously placed inconnection with a conventional intravascular diagnostic or treatmentprotocol, such as angiography, angioplasty, atherectomy, laser ablation,cardiac mapping, cardiac ablation, or the like. The device 10 isintroduced with the needles 20 compressed radially inward so that theywill fit within the internal diameter of the sheath S. A particularadvantage of the device 10 is that it can be introduced over theguidewire GW which has been used for performing the previous procedures.Thus, should it be necessary for any reason, the guidewire GW willremain in place until the very end of the suturing procedure.

As illustrated in FIG. 8, after the distal end of the device 10including the needles 20 has reached the lumen of the blood vessel BV,the introducer sheath S will be partially withdrawn, permitting theresilient needles 20 to open radially outward so that the barbed tips 40are disposed on opposite sides of the blood vessel wall tract P.

The user next draws proximally on the handle 58, causing the shaft 14 tomove proximally relative to the sleeve 12. Proximal motion of the shaft14, in turn, causes the needles 20 to penetrate through the blood vesselwall BV, with the arcuate shape of the needles causing the needles tomove radially inward back toward the shaft 14. Continued proximal travelof the shaft 14 causes the stop member 46 to engage the distal end 70 ofthe sleeve member 12. Continued proximal travel of the shaft 14 thuscauses axial compression of the sleeve 12, expanding individual ribs 42,as described above. The relative positions of the ribs 42 and needles 20are chosen so that the expandable cage opens into the needles' path asthey are brought backward through the blood vessel wall BV andsurrounding tissue. The barbed ends 40 of the needles 20 are thus ableto penetrate the fabric or mesh 32 carried on the expandable cage toengage and secure the needles. The situation where the needles have beensecured is illustrated in FIG. 9.

After the needles 20 are captured, the handle 58 is released, causingthe shaft 14 to distally advance under the urging compression spring 60.Such distal motion of the shaft 14 causes the needle retainer 22 to moveaway from the needles 20 which are held by the fabric or mesh 32 on theexpandable cage structure, as illustrated in FIG. 10.

The device 10 may be drawn outward through the introducer sheath S,leaving the suture 30 behind (passing through the two needlepenetrations made in the blood vessel wall BV and overlying tissue). Thefree ends of the suture 30 will thus be drawn outward through thepercutaneous tract P, as illustrated in FIG. 11.)

At this point, it will be possible to secure the free ends of the suturetogether, e.g., by tying to form a knot 72 which can be pushed downwardusing a pusher rod 74, as illustrated in FIG. 12. The introducer sheathmay be removed either before or after the knot 72 is put in place. As analternative to tying, various fasteners can be used to secure the freeends of the suture together, either alone or in combination withknotting.

In a preferred option of the present invention, a locking fastener 80may be inserted over the free ends of the suture 30 using a fastenerapplier 82, as illustrated in FIG. 13. The locking fastener 80, incombination with a tied suture loop, provides a particularly securebarrier against bleeding, without having the disadvantages of thehemostatic fasteners which have previously been used.

The fastener applier 82 comprises a shaft 84 including a pair of axialprongs 85 and an axial rod 86. As best illustrated in FIGS. 14 and 15,the axial prongs 85 terminate in outwardly disposed tips 88 which arereceived in receptacle wells 90 formed in a rear surface 89 of thelocking fastener 80. The axial prongs 85 are resilient and tend tospring radially outward, thus allowing the tips 88 to hold the fastenermember 80 by engaging the well receptacles 88. The locking fastener 80can be placed over the ends of suture 30 through slots 92 formed onopposite sides of the fastener.

Referring now to FIGS. 16 and 17, after the suture 30 has been drawn outthrough the tract P and introducer sheath S, fastener 80 is introducedover the suture 30 using the applier 82. Once the fastener 80 ispositioned a proper distance over the blood vessel BV, as illustrated inFIG. 17, the suture applier will be rotated to twist the suture, asshown at 96. A knot 98 may then be tied in the remaining free ends ofthe suture 30 and pushed downward over the fastener 80 to secure thefastener in place.

Alternate locking fastener embodiments are illustrated in FIGS. 18-23.In FIGS. 18 and 19, a locking fastener 100 includes a cylindrical cavity102 which would permit the fastener to be placed closely over the bloodvessel. In FIGS. 20 and 21, the fastener 104 includes a concavehemispherical recess 106 which would also permit close placement of thefastener over a blood vessel wall. Finally, in FIGS. 22 and 23, fastener108 includes a flat face 110 which would also be suitable for use in thepresent invention.

In addition to tying and use of a fastener, the present invention willencompass other devices and approaches for securing the suture as willbe readily apparent to one skilled in the art.

Referring now to FIGS. 24-27, a second embodiment of the suture applyingdevice of the present invention will be described. Suture applyingdevice 200 comprises an introducer sheath 202, a support sheath 204, acapture sleeve 206, a guide sleeve 208, and a needle shaft 210. Thecapture sleeve 206 will be mounted coaxially over the guide sleeve 208,and the guide sleeve 208 in turn will be mounted coaxially over theneedle shaft 210, in order to form a needle advance and capture assembly212, as illustrated in FIGS. 27A and 27B. The introducer sheath 202 willinitially be mounted within the support sheath 204 in order tofacilitate introduction of the support sheath into a previously formedpercutaneous tract, with only the thinner tip 280 of the introducerprojecting into the arteriotomy and the shoulder 281 stopping at or nearthe superficial wall of the artery. After introduction of the supportsheath 204, the introducer sheath 202 will be removed, and the needleadvance and capture assembly 212 will be introduced through a lumen ofthe support sheath, as will be described in more detail hereinafter.

Referring now to FIGS. 24 and 27B, the needle holder 210 comprises anelongate rod 220 having a needle support holster 222 at a distal endthereof and a knob 224 at a proximal end thereof. The needle supportholster 222 carries at least one pair of opposed needles 226, usuallycarrying two pair of opposed needles as illustrated. As best observed inFIG. 27B, the needles 226 will initially be held at their proximal endsin the support holster 222 with their distal ends being positioned in aguide member 228 secured to the distal end of the guide sleeve 208. Itwill be appreciated that the needles 226 can thus be advanced proximally(i.e., in an upward direction as illustrated in FIG. 27B) by drawing theneedle shaft 210 proximally relative to the guide sleeve 208.

The guide member 228 includes a plurality of guide channels or lumens230 for receiving the needles 26. The guide channels 230 will beoriented so that the needles 226 are deflected radially outward relativeto the needle advance and capture assembly 212 as the needles areadvanced proximally relative to the guide sleeve 208. Such radialdeflection assures that the needles will penetrate tissue away from thearteriotomy, as best observed in FIG. 30B, described hereinafter.

The needles 226 will typically be formed of a very resilient metal,which will allow the needles to negotiate the relatively sharp bendleading into the arterial lumen of the femoral artery FA, as best seenin FIG. 29. In particular, the needles will be configured in a straightshape but will be able to bend into a slightly arcuate path aftercrossing the tissue to be sutured and then being deflected inwardly backinto the lumen of support sheath 204 by a ridge 239 on the inner wall ofsupport sheath 204, where they will be captured on the capture sleeve206, as described in more detail hereinafter. A preferred material forfabricating the needles is a nickel-titanium alloy in its superelasticcondition, but a high tensile strength stainless steel may also be used.

The capture sleeve 208 comprises a cylindrical body 234 having a centrallumen extending from an open distal aperture 236 to a proximal handle238. The guide sleeve 208 will be slidably received within the lumen ofthe capture sleeve 206, with the guide member 228 extending out of theopen distal aperture 236, as best observed in FIGS. 27A and 27B. Thecapture sleeve 206 includes a capture target 240 which is convenientlyan annular disk secured to the exterior of the sleeve. The capturetarget 240 may be composed of any material which is easily penetrable bythe needles 226 and which can serve to capture the distal ends of theneedles so that they may be drawn outwardly by the target as the capturesleeve 206 is pulled via handle 238 so as to disengage needles 226 fromsupport holster 222 and pull needles 226 through guide member 228 andclear of arterial tissue of the femoral artery FA surrounding thepuncture site and into the lumen of support sheath 204 as describedhereinafter. A second annular disk 242 is provided on the sleeve 206proximally of the capture target 240, to assist in centering capturesleeve 206 within support sheath 204. Suitable materials for thesecomponents include nylon, delrin, polycarbonate, and other moldable orextrudable materials.

Referring now also to FIGS. 25, 26A, and 26B, the proximal end of guidesleeve 208 includes a cage structure 250 having an H-frame whichcomprises parallel axial tracks 252, a top bar 254, and a middle bar256. An elliptical or oblong ring 258 is part of the distal ends of theparallel tracks 252 in such a way that the tracks can be spread apart(as illustrated in FIG. 26A) with the ring acting as a spring.Conveniently, the user may spread the tracks 252 apart by compressingthe elliptical ring 258 along the longer elliptical axis. The innersurfaces of the distal portions of parallel tracks 252 comprise gearteeth 260 which mate with gear teeth 262 on a proximal end of thesupport sheath 204. It will be appreciated that the gear teeth 260 and262 will mesh to hold guide sleeve 208 in a fixed position relative tothe support sheath 204 at all times except when the parallel tracks 252are spread apart by compressing the elliptical ring 258. As described inmore detail hereinafter, this feature allows the user to introduce theneedle advance and capture assembly 212 to a desired depth relative tothe support sheath 204 and thereafter leave the assembly at the desiredposition until it is time to remove the entire capture assembly 212.

Prior to use, the needle advance and capture assembly 212 will be in theconfiguration illustrated in FIGS. 25, 27A and 27B. That is, the needleshaft 210 will be in its most distal position relative to the guidesleeve 208. Knob 224 attached to needle shaft 210 will lie adjacent themiddle bar 256 of the cage structure 250. The capture sleeve 206 willlie in its most proximal position relative to the guide sleeve 208, withknob 238 lying adjacent the elliptical ring 258. In use, it will beappreciated that the needle shaft 210 will first be drawn proximally viathe handle 224 in order to pass the needles 226 through the site to besutured, and into engagement with the capture target 240 which is anintegral part of capture sleeve 206 to effect capture of needles 226.Such a method will now be described in greater detail in connection withFIGS. 28-33.

The method of utilizing device 200 begins by inserting the supportsheath 204 having introducer sheath 202 in place within its centrallumen. The introducer sheath 202 defines a tapered end 280 which may beintroduced over a guidewire 282 which has previously been placed in thepercutaneous tract P and the puncture site A through the femoral arteryFA as part of an earlier procedure. A proximal end 284 of the introducersheath 202 extends outward from the proximal end of the support sheath204, and the introducer sheath will be composed of a resilient materialwhich allows the introducer sheath to be collapsed and withdrawn fromthe support sheath after the support sheath is properly positioned.Conveniently, the distal end of the support sheath 204 will have aserrated edge in order to help anchor the support sheath in place withinthe tract P and centered around the puncture site. As illustrated inFIG. 28, the support sheath 204 includes a manipulation knob 286 havinga pointer 288 near its proximal end. The manipulation knob 286 allowsthe user to manipulate the combination of support sheath 204 andintroducer sheath 202 as they are being positioned within the tract P.The pointer 288 will be oriented in a predetermined direction relativeto the patient in order to facilitate positioning following theremaining steps of the method. Typically, the pointer 288 will beoriented toward the patient's head in a conventional cardiacinterventional procedure accessed through a femoral arteriotomy.

Referring now to FIG. 29, the needle advance and capture assembly 212will be introduced to the support sheath 204 after the introducer sheath202 has been withdrawn. The assembly 212 will be inserted into thesupport sheath 204 until the guide member 228 on the guide sleeve 208enters the lumen of the femoral artery FA through the arteriotomy A. Toassist the user in determining when the guide member has entered thefemoral artery FA, a blood inlet port 290 (best observed in FIGS. 24 and30) is provided near the distal end of the guide sleeve 208. Port 290 isconnected to a viewing port 292 through a lumen 294 (FIG. 26B). Theviewing port 292 incorporates a small vent (not shown) so that air mayeasily be expelled from the lumen 294 to permit blood flow to reach theviewing port, but is sufficiently small to restrict the outward flow ofblood from the viewing port. Thus, the user will be able to see bloodappear at the viewing port 292 as soon as the guide member 228 hasentered the femoral artery FA. At that point, the user can stopinsertion. The assembly 212 will be held in place relative to thesupport sheath 204 through the meshing of teeth 260 and 262 as describedpreviously.

With the needle advance and capture assembly 212 being fully introducedthrough the support sheath 204, the needles 226 will be fully introducedinto the femoral artery FA. In particular, the tips of the needles willlie on the superficial side of the arteriotomy in the artery wall.

Referring now to FIG. 30A and 30B, the needles 226 will be drawnproximally through the wall of femoral artery FA by pulling knob 224 ina proximal direction relative to the remainder of the device, asillustrated by arrow 300 in FIG. 30A. The knob 224 will draw the needleshaft 210 in the proximal direction which in turn causes the needlesupport holster 222 to push the needles in the direction of arrows 302and 304. The needle guide member 228 causes the needles 226 to flareradially outward so that they pass through the blood vessel wall, andinto engagement with the capture target 240 within the lumen of thesupport sheath 204 as illustrated in FIG. 30B.

The suture 310 (FIG. 31B) carried between adjacent pairs of needles 226will then be drawn downward through the support sheath 204, through thegap between the arteriotomy A in the femoral artery FA and the guidesleeve 208, through the punctures left by needles 226, and finally outthrough the lumen of the support sheath as the needles are first movedpartly outward by the action of knob 234, and then carried outward bythe target 240 with the removal of the entire capture assembly 212 fromsupport sheath 204.

Referring now to FIG. 32, the preferred pattern of four needles beingdelivered by the needle support holster 222, through the needle guidemember 228, and into the wall of the femoral artery FA is illustrated.It can be seen that the guide member 228 deflects the needles radiallyoutward so that the pattern of four needles engages the artery wall inan approximately square pattern about the arteriotomy A. After thesutures are tied and the knots advanced back through the support sheath204, the resulting pattern of tied suture will appear as in FIG. 33 whenviewed towards adventitial surface of the femoral artery FA surroundingthe arteriotomy A.

A third embodiment of the suture applying device of the presentinvention is illustrated in FIGS. 34-36. The device 400 comprises aguide body 402 and a needle shaft 404. The guide body 402 includes aguide tip 406 at its distal end, which guide tip includes a plurality ofguide channels 408 which receive the proximal ends of needles 410. Analigning arrow 403 is mounted on handle 405 located at the proximal endof the guide body 402. A marker lumen bubble 407 is located below thealigning arrow and serves to indicate when the distal end of the guidebody has entered a blood vessel, as described in connection withprevious embodiments. An indicator lumen 411 which permits the flow ofblood to the marker lumen bubble 407 is illustrated in FIGS. 35A and35B.

The needles 410 as illustrated comprise a sharpened tip section 412 andan elongate shank portion 414, but may also be manufactured as anintegral piece. The shank portion 414 will be sufficiently long so thatthe needles may be pushed from their butt end by a support holster 428fixedly attached to the needle shaft 404 in order to advance the needlesthrough the tissue to be sutured and fully through the guide body 402inserted together with support sheath 440 in the associated tract sothat no capture mechanism will be required, as with previousembodiments.

The guide body 402 further includes a plurality of needle lumens 420which are axially aligned and spaced about the periphery of the guidebody. As best seen in FIG. 35B, the needles 410 will enter the distalends of the lumens 420 as the needles are advanced proximally relativeto the guide body.

A flexible needle sheath 426 will be attached to the guide tip 406 ofguide body 402. The central lumen of the needle sheath 426 receives asupport holster 428 attached to the distal end of the needle shaft 404,as well as the needles 410. As with previous embodiments, the butts ofthe needles 410 are removably received within the support holster 428.The sheath 426 will be sufficiently long to permit the needles to extendat least 5 cm beyond the distal end of guide body 402.

Prior to use, the suture applying device 400 will be in theconfiguration illustrated in FIGS. 34 and 35A. That is, the needle shaft404 will be distally positioned within the guide body 402 and needlesheath 426. In particular, the tips of needles 412 will lie just at theguide tip 406 so that they may be easily advanced through the arterialtissue surrounding the arteriotomy. That is, the tips of the needleswill be generally retracted within the guide tip 406. A length of suture422 is attached to the proximal tips 412 of opposed pairs of needles410, with the connecting suture being stored in side lumens 427extending axially along the exterior of the needle sheath 426. As bestobserved in FIGS. 35A and 35B, the suture 422 extending between one pairof opposed needles is received in a first of the side lumens 427, whilethe suture extending between the other pair of opposed needles isreceived in the second of the side lumens. While it would be possible tostore the suture 422 in the lumens 420 of the guide body 402 (and thuseliminate the need for side lumens 427), such storage is less preferredsince it increases the risk that the suture will become entangled withthe needles 410 as they are withdrawn proximally. The use of side lumens427 greatly simplifies feeding of the suture as the needles 410 arewithdrawn.

After the guide tip 406 has been past through the puncture site to besutured, the needles may then be drawn proximally forward through thetissue to be sutured by drawing proximally on handle 430 at the proximalend of needle shaft 404. The method of the present invention will now bedescribed in more detail with reference to FIGS. 37-41.

The situation following an interventional or other vascular procedure,where the attending physician is satisfied that the puncture site may besealed, is illustrated in FIG. 37. A conventional introducer sheath isin place with a guidewire passing into the femoral artery. Theconventional introducer sheath is withdrawn after assuring that anappropriate guidewire for the suturing process is in place. The device400 (including a support sheath 440 which initially covers the ports tothe needle lumens 420) will then be introduced over the guidewire, asillustrated in FIG. 37. The needles 410 and sutures 422 mostly encasedby flexible needle sheath 426, will be fully advanced into the femoralartery FA past the arterial puncture site A. Handle 441 on supportsheath 440 is then partially withdrawn proximally to expose the needlelumens 420 (as shown in FIGS. 35A, 35B, and 38. Handle 430 will then bedrawn proximally outward relative to the guide body 402, causing theneedles 410 to pass through the superficial wall of the femoral arteryFA and into the needle lumens 420, as illustrated in FIGS. 35B and 38.The handle 430 may continue to be drawn proximally (i.e., outward fromthe patient) in order to continue to pull the needle shaft 404 throughthe guide body 402. Such movement of the needle shaft 404, in turn,continues to draw the needles 410 outward through the lumens 420 of theguide body 402 until the tips of the needles are exposed. The user maythen grasp the needles and continue to draw them out until the suture isavailable to the user. The guide body 402 may then be withdrawn from thesupport sheath 440, leaving a portion of the needle sheath 426 still inthe puncture site A to maintain hemostasis. The suture can then be tiedand the knot pushed back down through the support sheath 440. The knotwill then only be tightened when the needle sheath is finally withdrawnfrom the puncture site A.

Device 400 has certain advantages over the previous embodiments. Sinceit is not necessary to capture the needles using an internal capturemechanism, the needles need not have barbs. Such barbless needles willminimize trauma to the arterial tissue around the puncture site A andsimplify the procedure. The guide body 402 and guide tip 406 aredesigned as an integral structure to assure that needles 410 will beprecisely centered around the puncture site A, and will very reliablyenter the needle lumens 420 in guide body 402. Also, tip 406 willocclude the arteriotomy puncture during the performance of theprocedure, providing hemostasis. Moreover, the entire procedure issimplified, with fewer discrete steps being performed. The user needonly introduce the device over-the-wire and thereafter draw out theneedle shaft to carry the needles through the tissue to be sutured andoutward through the guide body, where the suturebecomes accessible andmay be tied in a conventional manner.

Although the foregoing invention has been described in detail forpurposes of clarity of understanding, it will be obvious that certainmodifications may be practiced within the scope of the appended claims.

What is claimed:
 1. A method for suturing a puncture site in a bloodvessel wall at the end of a tissue tract, the blood vessel wall having adistal side and a proximal side, said method comprising:forming at leasttwo penetrations in the blood vessel wall at the end of the tissue tractadjacent to the puncture site with at least one needle; passing a suturematerial through the two penetrations outwardly from the blood vesselwall to span the distal side of the puncture site; and drawing thepenetrations together with the suture material.
 2. The method of claim 1wherein the step of passing the suture material through the twopenetrations occurs simultaneously to span the distal side of thepuncture site.
 3. The method of claim 1 wherein the step of passing thesuture material through the two penetrations uses only one length ofsuture material.
 4. The method of claim 1 wherein the step of passingthe suture material through the two penetrations includes passing asingle strand of suture material through the penetrations.
 5. The methodof claim 1 wherein the step of passing the suture material through thetwo penetrations includes passing the suture material through thepenetrations from the distal side of the blood vessel wall.
 6. Themethod of claim 1 wherein the step of forming the penetrations includespenetrating a needle through the blood vessel wall.
 7. The method ofclaim 1 wherein the step of passing the suture through the penetrationsto span the distal side of the blood vessel opening includes pulling thesuture through each penetration with the needle used to form therespective penetration.
 8. The method of claim 7 wherein the needles arepassed from the distal side of a membrane to form the penetrations inthe blood vessel wall and pull the suture therethrough.
 9. A method ofsuturing a puncture site in a blood vessel wall, the methodcomprising:positioning a length of suture into a lumen of the bloodvessel; forming at least two penetrations in the blood vessel wall atthe end of a tissue tract adjacent the puncture site with more than oneneedle; passing a first end of a length of suture through one of thepenetrations outwardly from the lumen and a second end of the length ofsuture through another penetration outwardly from the lumen with theneedles; and securing the first and second ends of the suture to closethe aperture.
 10. The method of claim 9 wherein the passing stepincludes simultaneously passing the first end and second end of thelength of suture through at least two of the penetrations outwardly fromthe lumen.
 11. The method of claim 9 wherein the step of passing thesecond end of the suture through the penetrations includes pulling thesuture through each penetration with the needle used to form therespective penetration.
 12. The method of claim 11 wherein a firstneedle is used to form the first penetration and pull through the firstsuture end and a second needle is used to form the second penetrationand pull through the second suture end.
 13. The method of claim 12wherein both needles are passed from the blood vessel lumen to form thepenetrations in the blood vessel wall and pull the suture therethrough.14. A method for suturing vascular tissue, the method comprising:formingat least two penetrations in one or more layers of vascular tissue atthe end of a tissue tract with more than one needle; passing a first endof a length of suture through one of the penetrations and a second endof the length of suture through the other penetration with the needles;and securing the first and second ends of the suture to pull thepenetrations in one or more layers of vascular tissue together.
 15. Themethod of claim 14 wherein one of the penetrations is in a first layerand the other penetration is in a second layer of tissue.
 16. The methodof claim 14 wherein the step of passing the first and second ends of alength of suture material through the at least two penetrations occurssimultaneously.
 17. The method of claim 14 wherein the step of passingthe first and second ends of the length of the suture material throughthe at least two penetrations uses only one length of suture material.18. The method of claim 14 wherein the step of passing the suturematerial through the at least two penetrations includes passing a singlestrand of suture material through the penetrations.
 19. The method ofclaim 14 wherein the blood vessel wall has a distal side and a proximalside and the step of passing the suture material through the at leasttwo penetrations includes passing the suture material through thepenetrations from the distal side of blood vessel wall.
 20. The methodof claim 14 wherein the one or more layers of tissue have a distal sideand a proximal side and the needles are passed from the distal side ofthe one or more layers of vascular tissue to form the penetrations andpull the first and second ends of the length of the suture materialtherethrough.
 21. A method for suturing vascular tissue having a distalside and a proximal side, the method comprising:penetrating a layer ofvascular tissue at the end of a tissue tract with at least one needle;drawing a length of suture proximally through the penetration with theneedle; and detaching the length of suture from the needle to free thelength of suture for fastening to the same length.
 22. The method ofclaim 21 wherein the detaching step is performed on the proximal side ofthe tissue layer.
 23. The method of claim 21 wherein the drawing stepfurther includes retrieving the needle from the proximal side of thetissue layer.
 24. The method of claim 21 wherein the tissue layerincludes an aperture, the method includes the step of passing the lengthof suture distally through the aperture.
 25. The method of claim 21wherein the step of drawing a length of suture includes passing a singlestrand of suture material through the penetration.